A Comparative Bioavailability study of Different Curcumin formulations.
- Registration Number
- CTRI/2023/06/053361
- Lead Sponsor
- incy Benzy Joshua
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
1.Subjects who are willing to give their written informed consent and comply with the protocol requirements.
2.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening.
3.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study
1.Subjects who have consumed curcumin containing food 2 days prior to screening
2.Subjects having symptoms of viral infections
3.Pregnant or lactating women.
4.Subjects with known hypersensitivity to the investigational products.
5.Subjects who have participated in any clinical trial in the past 1 month.
6.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study.
7.Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the plasma concentrations of free curcumin in various curcumin products compared to standard curcumin after oral administration and hence to deduce the pharmacokinetics.Timepoint: 0.00h 1.00h, 3.00h, 5.00h, 8.00h
- Secondary Outcome Measures
Name Time Method Safety of study and biomarker analysis.Timepoint: Day 0, Period 1, Period 2,Period 3, Period 4, Period 5, Period 6, Period 7